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Exercise at Workplace for Manual Material Handling Workers

2019年4月16日 更新者:Rosimeire Simprini Padula、Universidade Cidade de Sao Paulo

Effectiveness of Exercise at Workplace for Manual Material Handling Workers

This study aim to evaluate the effectiveness of exercise at workplace for manual material handling workers. This is a randomized control trial study by cluster with three parallel groups (n=200). Participants will be randomized in three groups: (1) control group - will be receive ergonomics orientation . (2) Intervention group - exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - exercise at workplace three times per week, during 15 minutes.Outcomes: The outcome measure will be verified in three moments at baseline, in six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, physical activity level.

研究概览

详细说明

Objective: This study aim to evaluate the effectiveness of exercise at workplace for control and prevention nonspecific low back pain. Methods: This is a randomized control trial study by cluster with three parallel groups. The context of this study is a motorcycle parts company importer localized in several states (Piaui, Ceará e Maranhão). The company has 575 workers, being 240 manual material handling. All are men over 18 years old that perform goods shipment (each work develop one this tasks - stock, separation, conference and packaging).

The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form. The exclusion criterial were sick leave. The workers will be included with low back pain or no low back pain (at baseline). All will be interviewed to obtain: weight, height, BMI, age, marital status, educational level, and actual function (stock, separation, conference and packaging sick leave (the last 12 months), musculoskeletal complains, medications, complementary exams, surgery and or fractures. Participants will be randomized in three groups: (1) control group - will be receive orientation about manual material handling, postural and low back care (lecture and guidance). The training will be instructions according Ergonomics standard (NR17) about transportation and load handling and exercise in workout. (2) Intervention group 1 - will receive the same instruction of the control group, and will perform exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - will be receive the same instruction of the control group, and will perform exercise at workplace three times per week, during 15 minutes. Outcomes: The outcome measure will be verified in three moments at baseline, six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, exercise workout.

Expected Results: The manual material handling workers will be better after intervention by exercise at workplace. The effectiveness of exercise for low back pain and no low back pain groups will be contribute to change the behavior in occupational context.

研究类型

介入性

注册 (预期的)

240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • São Paulo、巴西、12942770
        • 招聘中
        • Rosimeire Simprini Padula
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form.

Exclusion Criteria:

  • The exclusion criterial were sick leave

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
无干预:Control Group
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance).
有源比较器:Intervention group 1
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance), and will perform exercise at workplace three times per week, during 15 minutes
The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.
有源比较器:Intervention group 2
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance) and and will perform exercise at workplace four times per week, during 15 minutes.
The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from Pain Intensity at 6 months
大体时间:At baseline and after six months
Likert scale (0-10 points)
At baseline and after six months
Change from electromyographic signal at 6 months
大体时间:At baseline and after six months
RMS (root mean square error) signal and peak signal by Electromyographic (EMG)
At baseline and after six months

次要结果测量

结果测量
措施说明
大体时间
Change from palmar grip strength at 6 months
大体时间:At baseline and six months
Three measure palmar grip strength to use the mean by dynamometer
At baseline and six months
Change from body mass index at 6 months
大体时间:At baseline and after six months
The body mass index will be calculated on height divided by square weight
At baseline and after six months
Change of behavior to exercise
大体时间:At baseline and after six months
Practice of exercise (practice - yes or no; number of times per week)
At baseline and after six months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年7月25日

初级完成 (实际的)

2018年12月19日

研究完成 (预期的)

2020年12月17日

研究注册日期

首次提交

2018年4月29日

首先提交符合 QC 标准的

2018年7月20日

首次发布 (实际的)

2018年7月24日

研究记录更新

最后更新发布 (实际的)

2019年4月17日

上次提交的符合 QC 标准的更新

2019年4月16日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2.372.435

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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